Form 8-K NANOVIRICIDES, INC. For: Sep 21
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): September 21, 2021
|(Exact Name of Registrant as Specified in Its Charter)|
|(State or Other Jurisdiction of|
|(Commission File Number)||(I.R.S. Employer Identification No.)|
|1 Controls Drive, |
|(Address of Principal Executive Offices)||(Zip Code)|
(Registrant's Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class:||Trading Symbol(s)||Name of each exchange on which|
|Common Stock, par value $0.0001||NNVC||NYSE-American|
Item 7.01. Regulation FD Disclosure.
On September 21, 2021, NanoViricides, Inc. (the “Registrant”) was advised that certain articles were published, prior to the opening of trading, by a third party based on certain information that the Registrant has not yet publicly released. The third party had received the information confidentially under embargo from our Public Relations provider. The Registrant had advised and confirmed with the third party to extend the embargo in order to provide the Registrant’s management additional time to review and redraft the document into a final press release. Unfortunately, due to a human error in moving the embargo date, the third party inadvertently published their articles based on the draft information. This information has not yet been released by the Registrant as of this date.
The Registrant believes that the statements contained in the Registrant’s information document (attached) are reasonably accurate, although they have not been fully vetted in their final form and do not contain typical safe harbor disclosures regarding forward-looking statements. The Registrant expects to fully vet the contents and publish the information on or before Tuesday, September 28, 2021, before 7:00 am EST, which may be substantially different than the attached draft.
The furnishing of the attached information is not an admission as to the materiality of any information therein. The information is summary information that is intended to be considered in the context of more complete information included in the Registrant’s filings with the U.S. Securities and Exchange Commission (the “Commission”) and other public announcements that the Registrant has made and may make from time to time by press release or otherwise. The Registrant undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K except to the extent required by applicable law, although the Registrant may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosures. This information should be read in conjunction with the risk factors and other information contained in the Registrant’s filings with the Commission.
This Form 8-K and the Exhibit contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Registrant’s control. These statements are also based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Registrant. to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Registrant assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the Registrant’s expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
Item 8.01 Other Events.
The disclosures set forth in Item 7.01 are hereby incorporated by reference into this Item 8.01.
Item. 9.01. Financial Statements and Exhibits.
|99.1||Draft Information Document|
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.
|Date: September 21, 2021||By:||/s/ Anil Diwan|
|Name: Anil Diwan|
|Title: President, Chairman|
Significantly Improved Safety Profile and Metabolism of Remdesivir Observed
Due to Encapsulation in NanoViricides Drug Candidate Enabling Potential
Highly Effective Pan-Coronavirus Antiviral Drug
Shelton, Connecticut -- September 21, 2021 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the significant advantages gained by remdesivir encapsulation within its lead COVID-19 candidate NV-CoV-2 thereby producing a potential pan-coronavirus cure, NV-CoV-2-R to finally overcome the current global pandemic.
Pharmacokinetics of Remdesivir
Almost double the remdesivir remained intact in plasma when given as the encapsulated NV-CoV-2-R form, in comparison to the standard remdesivir formulation in SBECD, during the first day of dosing, in a rat study. Additionally, remdesivir accumulation was observed on repeated dosing of NV-CoV-2-R. After the fifth dose of NV-CoV-2-R (on day 7), and following the standard remdesivir dosing pattern (twice on day 1 followed by daily thereafter), the circulating level of remdesivir in plasma was 75% greater in the NV-Cov-2-R group as compared to the remdesivir group. The data were normalized to reflect the same amount of remdesivir given to the animals per kg body weight for uniform comparison. The studies were performed using the well established isotopic internal standard method of remdesivir estimation with LCMS detection.
This increased intact circulating level without any increase in toxicity is significant. It can be expected to result in improved antiviral effectiveness of the remdesivir component in human usage. This is important because remdesivir is a highly effective drug in cell culture and pre-clinical studies but does not show superior effectiveness matching the preclinical studies in humans because of its rapid metabolism. There is very little margin to increase remdesivir dosing in its standard form because of dose limiting toxicity.
These data demonstrate that the pan-coronavirus nanopviricide drug candidate NV-CoV-2-R minimizes the loss of remdesivir to bodily metabolism. The Company anticipates that this stabilizing effect should lead to a highly effective pan-coronavirus drug that could potentially cure most cases of COVID-19 infection.
Both remdesivir and NV-CoV-2 have demonstrated broad-spectrum activity against coronaviruses. Thus NV-CoV-2-R is expected to continue to be active in spite of evolution of novel variants of SARS-CoV-2. In contrast, antibody drugs and vaccines which induce antibodies lose effectiveness against variants. The more the variant drifts from the original strain, the less protection is offered by vaccines, and effectiveness of antibodies also diminishes significantly. This is now known to be occurring for current vaccines and antibodies during the global COVID-19 pandemic.
NV-CoV-2-R combines (1) the power of the nanoviricides® platform attacking the virus particle outside cells with (2) the power of remdesivir in attacking the virus reproduction inside cells. Additionally, we believe that (3) NV-CoV-2-R would be improving the effect of remdesivir by (i) enabling a higher effective concentration of remdesivir in the body and (ii) sustaining this higher concentration for a substantially longer period of time, both compared to the standard formulation of remdesivir.
NV-CoV-2-R combines two different mechanisms of attack against the virus and therefore is expected to be substantially more difficult for the virus to evade than either NV-CoV-2 or remdesivir alone. This is important because scientists believe it is only a matter of time before variants of SARS-CoV-2 that evade current vaccines and antibody drugs become commonplace.
Both NV-CoV-2 and remdesivir are expected to retain their effectiveness against variants of SARS-CoV-2. NV-CoV-2 has shown effectiveness against multiple unrelated coronavirus types. Remdesivir has been demonstrated to possess antiviral activity in cell culture against a large number of RNA viruses.
The clinical effectiveness of remdesivir is limited by bodily metabolism which turns a substantial portion of the injected drug into an inactive form. The protection from metabolism that is provided by e
Remdesivir, while effective in cell cultures, has not demonstrated a level of clinical effectiveness that such strong antiviral effect could muster. This has been related to the fact that remdesivir is rapidly metabolized in the bloodstream and its effective concentration at the site of action may therefore not reach the levels necessary. The standard Veklury® formulation of remdesivir in betadex sulfobutyl ether sodium (SBECD) helps with suspending remdesivir in solution, but does not appear to significantly improve upon the metabolic effects.
NanoViricides, Inc. has developed NV-CoV-2-R, a drug candidate that encapsulates remdesivir in the Company’s pan-coronavirus drug candidate NV-CoV-2 to solve this problem.
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